The U.S. Food and Drug Administration (FDA) granted a supplemental approval for Enhertu (fam-trastuzumab deruxtecan-nxki) on 2025-01-27. This approval pertains to an efficacy supplement, indicating an expansion or modification of the drug's approved uses based on new data.
Background
Trastuzumab Deruxtecan, marketed as Enhertu, is the subject of this supplemental efficacy application. The application, identified as BLA 761139 S-32, was sponsored by DAIICHI SANKYO.
What this means
This supplemental efficacy approval for Enhertu signifies that the FDA has reviewed and acknowledged new data supporting the drug's effectiveness. While the specific details of the new indication or patient population are not provided in the available information, such approvals typically expand the drug's label to include additional uses or refine existing ones. Clinicians and researchers should consult the full FDA label for Enhertu following this approval to understand the precise implications for patient care and treatment strategies.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for BLA 761139 S-32 for Enhertu (fam-trastuzumab deruxtecan-nxki) was posted on 2025-01-27 on accessdata.fda.gov.